tDCS plus Action Observation Therapy for leg function in children with diplegic CP
Official title: Additional Effects on Transcranial Direct Current Stimulation (tDCS) With Action Observation Therapy on Lower Limb Functions on Children With Diplegic Cerebral Palsy
Run by Riphah International University · NCT07921095 · Data updated 2026-11-12
This study tests whether adding active brain stimulation to action observation therapy can improve leg movement in kids with diplegic cerebral palsy better than a sham stimulation with the same therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 15 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Wah, Punjab Province) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | November 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07921095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 with diplegic cerebral palsy, MAS 2, and CFCS Level II.
✕Probably not a fit
Children without responsiveness to tDCS or with disqualifying medical conditions may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines the combined use of active transcranial direct current stimulation (tDCS) with Action Observation Therapy (AOT) to improve gross motor function in children with spastic diplegic cerebral palsy. Participants are randomized to receive either active tDCS plus AOT or sham tDCS plus AOT, aiming to isolate the effect of brain stimulation on outcomes. Assessments include GMFM-88 for gross motor function, MAS for spasticity, and walking speed (10-meter walk test) at six weeks post-intervention. Eligible children are aged 6–12 with MAS = 2, CFCS Level II, and no contraindications to tDCS or participation. The trial is conducted at Alam Family Hospital in Wah, Punjab Province, led by Riphah International University.
Why it matters
Potential benefit: If successful, participants could see greater improvements in leg motor function and walking speed with the combined therapy.
How similar studies have gone: Previous work has explored tDCS or AOT separately; combining them in CP is a growing area with promising but not yet conclusive results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2 2. Age between 6 to 12 years old 3. Participants classified as Communication Function Classification System (CFCS) Level II 4. Participant with CFCS Level II Exclusion Criteria: 1. Presence of uncontrolled epilepsy (any seizure within the past 6 months). 2. Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator). 3. Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function. 4. Severe visual impairment (not correctable with aids) preventing participation in action observation tasks. 5. Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period. 6. Orthopedic surgery to the affected limb(s) within the past 12 months or planned during study period. 7. Skin conditions, lesions, or infections at electrode placement sites. 8. Current use of medications significantly affecting cortical excitability (e.g., high-dose benzodiazepines, anticonvulsants), unless cleared by neurologist. 9. Participation in another interventional clinical trial within the past 3 months. 10. Any medical or psychiatric condition that, in the investigator's judgment, makes participation unsafe or interferes with study outcomes.
Where it's running
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Alam Family Hospital
Wah, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Ayesha Bashir — Riphah International University
- Study coordinator: Dr. Ayesha Bashir, MS-NMPT
- Email: ayesha.bashir@riphah.edu.pk/
- Phone: +923335256920
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.